Using Three Different Final Irrigants and Showing Their E... | NCT03591172

Studies
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization

NCT03591172

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 19, 2018Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Post-operative Pain

Interventions

Propolis
Nano-propolis
saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

Nov 2018Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jul 18, 2018

First Posted Date

Jul 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.

Detailed Description

Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propolis	Experimental	natural antibacterial, anti-inflammatory irrigation solution	Drug: Propolis
Nano-propolis	Experimental	natural antibacterial, anti-inflammatory irrigation solution	Drug: Nano-propolis
saline	Active Comparator	sodium chloride irrigation solution	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propolis	Drug	Using propolis as a final irrigation in revascularization	propolis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post-operative pain: Visual analogue scale	post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.	1 year

Secondary Outcomes

Measure	Description	Time Frame
periapical healing	evaluated radiographically	1 year
sensitivity	electric pulp tester	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mature teeth.
teeth with periapical periodontitis.
Maxillary anterior teeth
Patients should be free from any systemic disease
Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

Patients with immature roots.
Patients with any systemic disease that may affect normal healing.
Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011429	Propolis
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D012116	Resins, Plant
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided